FDA Publishes Official Validation Rules for Submission Data

November 18, 2014

This morning, November 18th, the Food and Drug Administration (FDA) published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

The FDA is asking sponsors to validate their study data before submission using these published validation rules and either correct any validation issues or explain, why they could not be corrected, in the Study Data Reviewer's Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission.

Rest assured: we have implemented the new FDA validation rules in the upcoming OpenCDISC Community 2.0 — keeping you ahead of the curve. Please join Sergiy Sirichenko — co-founder of OpenCDISC and an FDA Data Fitness Analyst — to learn about the new FDA validation rules and how you can get compliant in time for your next submission.

Note: We offer two sessions to accomodate different time zones. The content is identical.

WEBINAR SESSION 1 WEBINAR SESSION 2
Date: Tue, Dec 2, 2014
Time: 9:00 am EST
(15:00 CET)
Length: 1 hour
Date: Wed, Dec 3, 2014
Time: 2:00 pm EST
(11:00 am PST)
Length: 1 hour
Register Register

In this webinar, we will cover:

  • FDA Study Data Technical Conformance and related guidances
  • Conformance vs. Quality validation rules
  • Purpose, structure, and content of the new FDA validation rules
  • Comparison of FDA validation rules to rules defined by OpenCDISC Validator 1.5
  • Using OpenCDISC Community 2.0 to comply with FDA submission requirements

Best regards.
OpenCDISC Team